跳至主要内容
临床试验/NCT04871100
NCT04871100进行中(未招募)不适用

Addressing Mental Health Comorbidities: Integrated CBT to Improve Functioning in Veterans With Co-Occurring Anxiety and Substance Use

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Addiction Severity Index

研究概览

简要总结

Individual with anxiety and post-traumatic stress disorder often use alcohol in ways that could cause them harm. Treating both mental health concerns and alcohol use at the same time can help reduce difficulties engaging in multiple treatments. The investigators are evaluating how a cognitive behavioral therapy program that helps Veterans with anxiety, posttraumatic stress disorder, and alcohol use at the same time can help improve the participants lives.

详细描述

Co-occurring hazardous drinking, anxiety disorders, and PTSD are problematic combinations of mental health concerns experienced by deployed Veterans. Veterans who have been deployed are at particular risk for experiencing problems in functioning and reintegration related to mental health disorders and hazardous drinking. Co-occurring anxiety and hazardous drinking heavily impact psychosocial functioning and quality of life. Although cognitive behavior therapy (CBT) can promote psychological recovery through improvements in functioning and quality of life, most CBT protocols do not address co-occurring disorders, leading to inefficient and disjointed treatment. The current research seeks to adapt and test the Unified Protocol (UP) for deployed Veterans with hazardous drinking. The use of combined CBT for both anxiety disorders and hazardous drinking has the potential to more efficiently and effectively improve functioning, reduce symptoms, and promote psychosocial recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • meeting diagnostic criteria for current anxiety disorder and
  • endorsing hazardous alcohol use

排除标准

  • need for acute medically-supervised detoxification with exclusionary criteria of
  • high-risk suicidality
  • psychotic symptoms, or
  • cognitive impairment that could interfere with engagement in weekly psychotherapy

研究组 & 干预措施

Enhanced Usual Care

Active Comparator

referrals to VA care for SUD and anxiety

干预措施: Usual care (Behavioral)

UP-A

Experimental

Cognitive behavior therapy using the Unified Protocol for Emotional Disorders with supplemental skills-based alcohol modules.

干预措施: Unified Protocol- Alcohol (Behavioral)

结局指标

主要结局

Addiction Severity Index

时间窗: 30 days

Assessment of substance use and related problems. Higher scores in each domain indicate problems related to substance use in that domain (range for each domain 0-1).

Social Adjustment Scale- Self Report

时间窗: 2-weeks

Evaluates individuals' satisfaction with social situation. Greater scores reflect greater social/occupational impairment (range 42-210).

Beck Anxiety Inventory

时间窗: past 30 days

Evaluates levels of anxiety in past month. Higher scores reflect greater anxiety (range 0-63).

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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